SUPPLY CHAIN ARTICLES
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![women gossiping-GettyImages-72131155]( "A \"Hot Take\" on Personalized mRNA Medicines")
A "Hot Take" on Personalized mRNA MedicinesmRNA’s small-scale and cell-free production are often-touted benefits in the personalized medicines sphere. But as I reviewed my notes from the BioPhorum ATMP member event, I found myself coming face to face with a difficult truth.
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![coronavirus covid-GettyImages-1220020527]( "FDA Sets Recommendations For Predicting Dangerous Nitrosamine Impurities")
FDA Sets Recommendations For Predicting Dangerous Nitrosamine ImpuritiesThe FDA recently published a final guidance that sets a recommended framework for predicting the potential of nitrosamine drug substance-related impurities.
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![Business Unity-GettyImages-1253212054]( "The RNA Therapeutics Supply Chain: A Platform of Relationships")
The RNA Therapeutics Supply Chain: A Platform of RelationshipsConversations digging into RNA-specific sourcing considerations have been few and far between. Enter Sanofi's Greg Troiano. Together, we delved into the nuances, challenges, and opportunities for growth that currently exist within the mRNA drug substance and drug product (i.e., mRNA-LNP) raw material sourcing worlds.
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![Key takeaways-GettyImages-1659816694]( "Plasmid Production: 3 Key Takeaways For mRNA Manufacturing")
Plasmid Production: 3 Key Takeaways For mRNA ManufacturingFollowing my latest Live panel on analytical and manufacturing technology innovations for mRNA production, I wanted to provide a few high-level takeaways I gleaned from our discussion on the overlooked darling of the mRNA space: The plasmid.
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![New Years Resolutions-GettyImages-1289531659]( "ARW's ATMP Manufacturing Must-Reads (2024 NEW YEAR'S RESOLUTIONS EDITION!)")
ARW's ATMP Manufacturing Must-Reads (2024 NEW YEAR'S RESOLUTIONS EDITION!)Day-in and day-out, I write, read, listen to, and watch as much content as I can about CGT and RNA therapy manufacturing, in particular, and/or other ATMP industry-related topics that you should at least be aware of in the manufacturing facility. Once a month, I compile the articles and industry updates I think are most worthy of your time into an unconventional newsletter format (below) and send them out via email.
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![Talimogene laherparepvec vaccine-GettyImages-960686030]( "Addressing Challenges In Serialization For Complex Therapeutics")
Addressing Challenges In Serialization For Complex TherapeuticsThe magnitude of serialization, especially for firms with extensive portfolios and intricate supply chains, poses serious challenges. This discussion offers solutions.
SUPPLY CHAIN VIDEOS
Learn how to build a resilient supply chain to navigate today's complex environment. Expert speakers share insights on optimization, innovation, and strategic planning to meet evolving market conditions.
Explore two functional areas that Advancing RNA panelists consider most essential to telling an RNA product’s “story” thoroughly to regulators.
Unlock the full potential of your pDNA purification with advanced chromatography solutions and resins that tackle high viscosity and impurities to ensure superior quality and yield.
We all know that plasmid quality is foundational in dictating the quality of the final mRNA drug substance. In this clip homing in on upstream process considerations, speakers Stu Sundseth (Tune Therapeutics), Marc Wolfgang (Sail Biomedicines), and Christian Dohmen (Ethris) outline some of the most important CQAs for plasmids and the impact they can have on the resulting quality of the mRNA drug substance for linear mRNA.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1297146235-dna]( "Review Of mRNA Vaccines & Therapeutics Manufacturing Challenges: Plasmid DNA Manufacturing")
This review suggests technical remedial options for the production of pDNA and focuses on mRNA synthesis, purification, and encapsulation.
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![iStock-1293772874-lab-plasmid-gene therapy-DNA]( "Novel Lipid Nanoparticle Delivery Reagent And Manufacturing Workflow")
We aim to highlight that commercially available LNP reagent mix, GenVoy-ILM, is an accessible and easy-to-use LNP formulation that allows for rapid preclinical development of RNA vaccines.
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![GettyImages-1059548518 global conntection]( "The Key To Improving Global Supply Chain Resilience")
Explore the past, present, and future of supply chain security, ways the biopharma industry can secure supply chains and minimize risks, and more.
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![GettyImages-1334686671-cold-chain-cryopreservation-logistics]( "Validate Cryopreservation As A Defined Input, Not A Variable")
Treating cryopreservation as a validated, controlled input improves consistency, quality, and patient outcomes by reducing variability across cell therapy manufacturing, storage, and distribution.
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![Quality-GettyImages-1360733079]( "Understanding The Hidden Value Of Quality")
Costs of poor quality (COPQ) cannot be overstated. Review the statistics that prove how costly it can be to avoid resolving quality issues in your processes and supply chain.
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![GettyImages-1418666846-scientist-lab-test-strip-vial]( "From LAL To rFC: The Evolution Of Endotoxin Testing")
Protect patient safety and ensure regulatory compliance by implementing sensitive, reliable bacterial endotoxin testing as a critical component of pharmaceutical quality assurance.
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![iStock-1087219198-lab-computer-cleanroom-research-development-production]( "GMP-Source® And Phase-Appropriate Use For Early-Stage Clinical Trials")
GMP-Source is a more robust, less rigid alternative to full cGMP production that mirrors nearly all of the oversight and quality standards of full cGMP production while relaxing certain commercial standards, helping companies overcome the hurdles that can stall early development.
